Kornimate/medical-research-clean huggingface dataset:
treatment for ulnar neuropathy at the elbow

Conditions: Peripheral Nervous System Diseases; Nerve Compression Syndromes; Cubital Tunnel Syndrome

Summary: the purpose of the study is to investigate utility and appropriateness of treatment interventions taking into account the presumed mechanisms of two main varieties of ulnar neuropathy at the elbow (une). the investigators hypothesize that in patients with une under the humeroulnar aponeurosis (hua) surgical hua release (simple decompression) is superior to conservative treatment. by contrast, in patients with une at the retroepicondylar (rtc) groove surgical hua release (simple decompression) should not be superior to conservative treatment.

ulnar neuropathy at the elbow (une) is the second most common focal neuropathy with annual incidence rate of 21 per 100.000. therefore, in slovenia une each year affects approximately 420 and in europe 156.000 patients. in previous publications evidence was presented that idiopathic une consists of two conditions occurring 2-5 cm apart. in the first condition, affecting about 15% of une patients, the ulnar nerve is entrapped 2-3 cm distal to the medial epicondyle (me) under the humeroulnar aponeurosis (hua), i.e., in the cubital tunnel. in the second condition, affecting the majority (about 85%) of patients, the lesion is located at the me or up to 4 cm proximally in the retroepicondylar (rtc) groove. as no anatomical structure constricting the ulnar nerve is usually found in that segment, the most probable cause of une at this location is extrinsic ulnar nerve compression against the underlying bone. the investigators believe that these two groups of une patients need different therapeutic approaches: (1) surgical release for ulnar nerve entrapment distal to me and (2) conservative treatment for extrinsic nerve compression in the rtc groove. the efficiency of this therapeutic approach was already evaluated and significant clinical improvement was found in 80% of une patients. however, the design of that study did not enable to obtain an indisputable evidence that outcome was a result of treatment approach. it is still possible that improvement observed in patient population was a consequence of natural history rather than therapy. to resolve this problem a properly designed randomized control trial is needed. the investigators believe such trial would prevent numerous unnecessary and delayed operations in une patients.

Eligibility criteria:
inclusion criteria: * continuous numbness or paresthesias in the 5th ﬁnger, * weakness of the ulnar-innervated muscles or hand clumsiness. exclusion criteria: * previous elbow fracture or surgery, * polyneuropathy, symptoms of polyneuropathy, conditions causing polyneuropathy (e.g., diabetes) or multiple mononeuropathy, * motor neuron disorders (e.g., monomelic amyotrophy, amyotrophic lateral sclerosis - als).

Keywords: ulnar neuropathy at the elbow electromyography ultrasonography treatment surgery conservative treatment
app-based symptom tracking after corona vaccination (cocov)

Conditions: Adverse Events in COVID-19 Vaccination

Summary: the study investigates the side effects of different covid-19 vaccines.

in this observational study side effects of covid-19 vaccines will be documented using an open-source mobile application. participants are invited to answer a questionnaire on a daily basis. common and unknown events are queried and collected. the primary result of this study will be a descriptive analysis of the collected data.

Eligibility criteria:
inclusion criteria: * received covid-19 vaccination * age ≥ 18 years * mobile device (ios or android) exclusion criteria: * no knowledge of german or english language * no written informed consent
validity and reliability of the mastitis symptom severity assessment methods (m-score and bissi) in non-lactational mastitis

Conditions: Granulomatous Mastitis; Mastitis Chronic

Summary: the purpose of this study is to evaluate the validity and reliability of the mastitis-score (m-score) and the breast inflammatory symptom severity index (bissi) as measures for assessing symptom severity in non-lactational granulomatous lobular/periductal mastitis (nl-glm/pdm). this research aims to provide a valid and reliable tool for evaluating both symptom severity and treatment efficacy in nl-glm/pdm.

non-lactational granulomatous lobular/periductal mastitis (nl-glm/pdm) are inflammatory breast diseases with unclear etiology, usually manifested as palpable breast mass, accompanied by breast pain and abscesses, erythema or fistula formation. there is no well-recognized assessment tool for evaluating the symptom severity and treatment efficacy of nl-glm/pdm. in our previous studies with nl-glm, we used the mastitis-score (m-score) as a physician-directed measure of the symptom severity. however, there were no patient-reported outcome measure for nl-glm/pdm. the breast inflammatory symptom severity index(bissi) was reported as a valid patient-reported outcome measure for lactational mastitis. its clinical validity as a measure of symptom severity for nl-glm/pdm are still unclear. in this multicenter, prospective cohort study, we will validate the validity and reliability of the m-score, a physician-directed measure, and the breast inflammatory symptom severity index (bissi), a patient-reported outcome (pro) measure, for assessing symptom severity in patients with non-lactational granulomatous lobular/periductal mastitis (nl-glm/pdm). establishing the validity of these two approaches will facilitate the objective measurement of treatment efficacy for nl-glm/pdm in the future.

Eligibility criteria:
inclusion criteria: 1. female, age between 18 and 65 years; 2. clinically considered as non-lactational mastitis; 3. clinically and pathologically confirmed nl-glm/pdm; 4. patients planning to receive treatment or observation alone; 5. signed the informed consent form exclusion criteria: 1. patients with confirmed or suspected malignant breast tumors 2. patients with bilateral mastitis (including those with bilateral non-lactational mastitis occurring simultaneously or successively) 3. pregnant.

Keywords: m-score validity reliability
dyad oxytocin study (dos)

Conditions: Schizophrenia; Autism Spectrum Disorder

Summary: the purpose of the investigators proposed study is twofold: 1) to investigate the role of the affiliative neuropeptide oxytocin in unhealthy interactions in families of patients with schizophrenia and families of patients with autism spectrum disorder, and 2) to investigate whether manipulation of this oxytocinergic system positively influences these family interactions.


Eligibility criteria:
inclusion criteria: * inclusion criteria for caregiver of patients with schizophrenia, patients with autism spectrum disorder, and healthy controls: * age between 18 and 75 years old * must have at least 4 hours of contact with the patient per week and be considered a "significant caregiver" by the patient inclusion criteria for patients with schizophrenia: * between the ages of 14 and 45. * patients must have a diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychosis- not otherwise specified (nos). * patients must be clinically stable * no or minor changes to medications in the past week * patients must have a primary caregiver * inclusion criteria for healthy control child: * between the ages of 14 and 45 * healthy control must have a primary caregiver * inclusion criteria for patients with autism spectrum disorder * between the ages of 14 and 45 * patient must have a primary caregiver * patients must have a diagnosis of an autism spectrum disorder (asd) (autism or asperger's disorder), pervasive developmental disorder (pdd) or pervasive developmental disorder - not otherwise specified (pdd-nos). exclusion criteria: exclusion criteria for all caregivers: * female caregivers that state that they are pregnant or have a positive urine pregnancy test * caregivers who have significant nasal pathology, atrophic rhinitis, recurrent nose bleeds, or history of cranial-surgical procedures (hypophysectomy) * caregivers with significant psychiatric, neurologic, or medical illness * exclusion criteria for healthy controls: * healthy controls with history of psychiatric or neurological illness * exclusion criteria for patients with an autism spectrum disorder: * patients with an intelligence quotient (iq) lower than 75 * exclusion criteria for patients with schizophrenia * patients with severe brain trauma

Keywords: oxytocin schizophrenia autism spectrum disorder
registry for intra-operative radiotherapy during breast conserving surgery in patients with early stage breast cancer

Conditions: Early-stage Breast Cancer; Breast Carcinoma in Situ; Breast Neoplasms

Summary: this is a prospective, registry study that will enroll all women with early stage breast cancer who will be treated with intraoperative radiotherapy (iort) during breast-conserving surgery. the purpose of this study is to further validate the long-term effectiveness and safety of this treatment method. we aim to assess short and long-term patient outcomes associated with iort, including perioperative complications, local and distance disease recurrences, as well as disease-free survival and overall survival.

at providence saint john's health center, there is the ongoing integration of intra-operative radiation therapy (iort) as a standard treatment option among breast conserving therapy (bct) for individuals with in situ and early stage breast cancer. currently, approximately 60 women per year are being treated with iort. no repository of information of patient outcomes with this treatment has been established. this leaves a critical gap in the ability to assess the long-term outcomes of patients treated with iort. as the practice of using iort to treat early stage and in situ breast cancer continues to grow at providence saint john's health center, this registry will provide the data needed to compare patient outcomes with those being treated with the traditional whole breast radiation therapy. in addition, the providence health \& services strives to improve patient care and outcomes with excellence whenever possible. the registry will provide the data needed to compare patient outcomes to national and community standards that can inform internal practice patterns and contribute to advancing breast cancer care nationally and internationally.

Eligibility criteria:
inclusion criteria: * clinical stage tis, t1, or t2(≤ 3cm), n0, m0 (ajcc classification) * unifocal disease * candidate for breast-conserving surgery * recommended treatment by multidisciplinary team exclusion criteria: * clinical stage t3-4, n1-3, m1 * multifocal disease

Keywords: breast cancer early-stage breast cancer intraoperative radiotherapy iort
ispinesib in subjects with platinum-taxane-refractory or resistant relapsed ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of this study is to determine how effective and safe a new investigational drug is in treating persistent or recurrent ovarian cancer in patients who have received a platinum/taxane based chemotherapy and whose disease continues to progress. the treatment involves a 1-hour treatment given intravenously (iv), and repeated once every 21 days. a patient may continue to receive the treatment as long as they are benefiting from the treatment. blood samples will be taken at specific times over a 24 hour period to measure the amount of drug in your body at specific times after the drug is given. blood samples will also be taken for routine lab tests such as complete blood counts and clinical chemistries. physical exams will be performed before each treatment.


Eligibility criteria:
inclusion criteria: * must have a screening ca-125 of greater than or equal to 40 u/ml. * must have received only one prior platinum/taxane-based chemotherapy regimen. * blood tests will be done to check if blood counts are adequate for taking part in the study. exclusion criteria: * received more than 1 chemotherapy regimen in the past or have less than adequate liver and kidney function. * females who are pregnant or nursing. * any unstable, pre-existing major medical condition or history of other cancers. * have received an investigational drug, chemotherapy, radiation treatment or surgery within 28 days prior to entering the study.

Keywords: ovarian cancer platinum/taxane-refractory chemotherapy persistent recurrent
characterization of the inflammatory profile of patients with macrophage activation syndrome secondary to bacterial sepsis

Conditions: Macrophage Activation Syndrome

Summary: the pathophysiology of macrophage activation syndrome has been mainly studied in pediatric genetic primary forms. there is little data in secondary forms related to bacterial sepsis. because of the seriousness of this entity (43% of deaths in intensive care in the largest cohort published so far by the medical resuscitation team of rouen university hospital), it is necessary to better understand the physiopathological mechanisms to be able to propose a suitable therapy. for now, the management of this syndrome is far from consensual. some authors advocate a single etiological treatment, while others suggest the need for intensive management of anti-inflammatory and immunosuppressive type. the fragility of resuscitation patients does not allow intensive immunosuppressive therapies as proposed by some authors. in the era of immunotherapy, the precise knowledge of physiopathological data would make it possible to propose a targeted therapy with little risk of adverse effects. recent work has indeed shown excellent tolerance of immunotherapy during sepsis and could be applied eventually in patients with macrophage activation syndrome.


Eligibility criteria:
inclusion criteria: patient hospitalized in intensive care for macrophage activation syndrome secondary to sepsis / bacterial septic shock with a strong clinical probability score (defined by a hscore\> 80% cf appendix 4) (experimental population) or patient hospitalized in intensive care for sepsis or septic shock (control population) * age ≥ 18 years * person affiliated with a social security scheme or beneficiary of such a scheme * trusted person or informed patient who has signed the consent to participate in the research. (if the patient is unable to sign his / her consent (emergencies) the consent will be signed by the person of trust, and consent to further study will be requested from the patient). * effective contraception in women of childbearing potential (negative pregnancy test). for postmenopausal women, a confirmation diagnosis should be obtained (amenorrhea for at least 12 months before the inclusion visit). exclusion criteria: * pregnant or breastfeeding woman * person deprived of liberty by an administrative or judicial decision * protected major subject, under tutorship or curatorship * patient participating in another interventional clinical trial with the same primary objective
the effect of ulnar nerve entrapment localization on ipsilateral upper extremity functions. the effect of ulnar nerve entrapment localization on ipsilateral upper extremity functions. the effect of ulnar nerve entrapment localization on ipsilateral upper extremity functions.

Conditions: Ulnar Neuropathies

Summary: regardless of the cause of ulnar nerve entrapment neuropathy, investigators are planning to explore the relationship between the ipsilateral upper extremity dysfunction that may develop due to ulnar neuropathy and the level of entrapment in electromyelography.


Eligibility criteria:
inclusion criteria: * having ulnar nerve entrapment neuropathy with clinical examination and emg (electroneuromyography) * to be between the ages of 18-65 * be give informed consent exclusion criteria: * inflammatory arthritis * hemiplegia * contractures of shoulder-arm-hand joints
patient controlled analgesia pump cues on patient satisfaction

Conditions: Postoperative Pain

Summary: to examine whether providing patients with a cue to the availability of pain medication affects patient satisfaction, patient anxiety, pca efficacy, and safety.

post-operative pain is primarily managed via patient-controlled analgesia (pca). the newest pca pumps can be programmed so that the button is backlit with a green light at the end of the lockout period, and the green light flashes when the medication is being dispensed. no studies have examined whether this type of visual cue would influence satisfaction or other patient outcomes (such as opioid consumption, pca safety and patient anxiety) in children and adolescents, and no studies have examined whether pediatric patients' perspectives would be similar to those of adults.

Eligibility criteria:
inclusion criteria: * 7-18 years * opioid naïve * scheduled for a surgery for which a pca is routinely used for post-operative pain management * at least 1 parent speaks english exclusion criteria: * prior experience with pca * cognitive delay precluding independent use of the pca button * current use of anxiolytics or antidepressants * patients receiving epidural analgesia
a pilot study to evaluate the clinical effectiveness and safety of the vfix device as treatment for apical prolapse

Conditions: Pelvic Organ Prolapse

Summary: the primary objective of this pilot study is to evaluate the safety and effectiveness of the vfix device in maintaining vaginal apical support for at least 6 months in women with symptomatic apical prolapse (upper vaginal or uterine prolapse).

assuming success of the vfix anatomical observational study (protocol 300-08-009), in this pilot study approximately 20 subjects (excluding the device run-in (dri) subjects) will undergo the vfix procedure to evaluate the safety and effectiveness of the vfix device in maintaining apical support for at least 6 months, in women with symptomatic apical prolapse.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * subjects of child bearing potential have a negative blood or urine pregnancy test prior to the procedure and subject has completed childbearing * subject with apical prolapse at stage ii or more and requiring treatment (c should be at least -1 cm) * on reduction of the apical prolapse, leading edge of prolapse should be at or above the hymen * if applicable, subject has small/normal size uterus and there is no elongation of the cervix as determined by clinical assessment * the vaginal apex can reach the sacrospinous ligament (ssl) on exam * subjects are allowed concurrent incontinence procedure as required * concurrent perineal repairs and excision of excess vaginal tissue repairs as required * agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the ethics committee approved informed consent exclusion criteria: * additional surgical intervention for pop repairs concurrent to the vfix procedure (including, but not limited to sacrocolpopexy, paravaginal repair, colporrhaphy, mesh repair, etc) * experimental drug or experimental medical device within 3 months prior to the planned procedure * active genital, urinary or systemic infection at the time of the surgical procedure. surgery may be delayed in such subjects until the infection is cleared. * previous hysterectomy within 6 months of scheduled surgery. * coagulation disorder or on therapeutic anticoagulant therapy (except aspirin) at the time of surgery * nursing or pregnant * presence of cancers of the vagina, cervix, or uterus * in the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol
efficacy of sialic acid gne related thrombocytopenia

Conditions: Thrombocytopenia

Summary: sialic acid-extended release (sa-er, aceneuramic acid, ux001) is an extended release formulation of sialic acid (sa, also known as n-acetylneuraminic acid or nana). the sa-er is currently studied as a substrate replacement therapy for patients with gne myopathy. the investigators plan to study the sa-er compound in a cohort of five patients with gne-related thrombocytopenia.

the investigators identified 5 affected individuals (3 males and 2 females from three families, age 19-40 years) with gne-related thrombocytopenia . all subjects will receive 2 gram sa-er, three times per day for a total daily dose of 6 grams (6,000 mg). the dose should be administered with food (i.e. within 30 minutes of a meal or snack). efficacy will be evaluated by improvement in clinical and laboratory assessments. results from baseline assessments will be compared with those of post-treatment assessments with efficacy conclusions based on improvement between baseline and the last scheduled assessment. safety will be evaluated by the incidence and frequency of adverse events, including clinically significant changes from baseline to scheduled time points in: * vital signs. * history and physical examination findings. * laboratory evaluations. * serum uric acid levels and urinary excretion of uric acid.

Eligibility criteria:
inclusion criteria: * patients with gne-related macrothrombocytopenia in the investigated family exclusion criteria: * non consenting for this study * pregnancy

Keywords: congenital macrothrombocytopenia sialic acid bleeding
dermal profile analysis using the nmr-mouse

Conditions: Exposure to Magnetic Field; Hypotension During Dialysis; Disturbance; Balance, Fluid

Summary: the determination of fluid status in dialysis patients is a major clinical problem. in this study the nmr-mouse is used to determine if it can be used to non-invasively determine hydration status of the skin. this evaluation will be performed in dialysis patients and healthy volunteers.

excretion of urine is impaired in terminal chronic kidney disease patients often requiring dialysis. fluid management of dialysis patients is solely based on body weight differences before and after dialysis. patients can suffer from either hypotension if too much fluid is eliminated by dialysis or from fluid-overload symptom (e.g. shortness of breath, edema) if not enough fluid is eliminated. in this study a mobile non-invasive nmr-mouse setup (a nuclear magnetic resonance spectroscopy measurement) is used to measure the hydration status of the skin.

Eligibility criteria:
inclusion criteria: * age 18-80 * dialysis * ability to perform nmr-measurement * eligibility to sign informed consent * signed informed consent exclusion criteria: * implanted cardiac device * implanted cranial device * implanted cochlea device * intrauterine device * other metallic implants * tattoo, any skin disease or scars from surgery (in the area of measurement) * previous skin treatment with cosmetics (of any kind) 24 hours prior to measurement * wearing of earrings, piercings or hearings-aids during measurement * participation in other clinical trials 30 days prior to participation in the shn study * no written informed consent * any conditions, as determined by the examiner, that excludes the patient from participation in the study * subjects with legal guardian * pregnancy or lactation (a possible pregnancy of a participant before menopause will be excluded before inclusion in the study) * subjects under employment or with any relation to the the sponsor or the investigator * participation in any other study